MediChoice WarmGel Infant Heel Warmer — Class II medical device recall Z-1300-2015
Terminated recall by CooperSurgical, Inc., reported 2015-03-25, distributed nationwide. Products without expiration date have the remote potential for minor burn
| Recall number | Z-1300-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-01-26 |
| Classified | 2015-03-19 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, BM, CA, FR, LV, MX, NZ, QA, SA, SG |
| Quantity | 18,696,754 units |
| Model numbers | 1643069911, 1643069912 |
Product
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
Reason for recall
Products without expiration date have the remote potential for minor burn
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1300-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.